scholarly journals Autobiographical memory-based intervention for depressive symptoms in young adults: A randomized controlled trial of cognitive-reminiscence therapy

2020 ◽  
Author(s):  
David John Hallford ◽  
David J. Mellor
Keyword(s):  
Young Adults ◽  
Depressive Symptoms ◽  
Usual Care ◽  
Autobiographical Memory ◽  
Meaning In Life ◽  
Controlled Trial ◽  
Care Group ◽  
Mediating Role ◽  
Reminiscence Therapy

Background: Autobiographical memory-based interventions have shown promise in the treatment of depression. This study is the first to examine the effects of one such therapy, cognitive-reminiscence therapy (CRT), for the treatment of depressive symptoms in young adults. Method: A total of 26 young adults (mean age = 20.8 years, SD = 1.9) presenting to a community youth mental health service for treatment of at least moderate depressive symptoms were randomized to receive either a six-week course of individual CRT or usual care (individual, brief evidence-based psychotherapy). Results: CRT had large effects on depressive symptoms at six-weeks (d = 1.59) and at a three month follow-up (d = 1.51). Effects were also found at six-weeks in the CRT group for variables suggested to play a mediating role: self-esteem, self-efficacy, meaning in life and optimism (d = .92 – 1.99), and at follow-up (d = .74 – 1.21). Effects were observed on anxiety symptoms at six-weeks (d = 1.78), but not maintained at follow-up. No within-group effects were observed in the usual care group, aside from optimism at six-weeks (d = 1.05), but not at three-months. Conclusions: This study provides preliminary findings that CRT is a feasible and promising approach to the alleviation of depression among young adults. However, larger trials are needed to test its effects more rigorously.

scholarly journals Inhaled budesonide for COVID-19 in people at higher risk of adverse outcomes in the community: interim analyses from the PRINCIPLE trial

2021 ◽  
Author(s):  
◽  
Ly-Mee Yu ◽  
Mona Bafadhel ◽  
Jienchi Dorward ◽  
Gail Hayward ◽  
...  
Keyword(s):  
Usual Care ◽  
Interim Analysis ◽  
Controlled Trial ◽  
Adverse Outcomes ◽  
Care Group ◽  
Primary Analysis ◽  
Open Label ◽  
Budesonide Group ◽  
Inhaled Budesonide

BACKGROUND Inhaled budesonide has shown efficacy for treating COVID-19 in the community but has not yet been tested in effectiveness trials. METHODS We performed a multicenter, open-label, multi-arm, adaptive platform randomized controlled trial involving people aged ≥65 years, or ≥50 years with comorbidities, and unwell ≤14 days with suspected COVID-19 in the community (PRINCIPLE). Participants were randomized to usual care, usual care plus inhaled budesonide (800μg twice daily for 14 days), or usual care plus other interventions. The co-primary endpoints are time to first self-reported recovery, and hospitalization/death related to COVID-19, both measured over 28 days from randomisation and analysed using Bayesian models. RESULTS The trial opened on April 2, 2020. Randomization to inhaled budesonide began on November 27, 2020 and was stopped on March 31, 2021 based on an interim analysis using data from March 4, 2021. Here, we report updated interim analysis data from March 25, 2021, at which point the trial had randomized 4663 participants with suspected COVID-19. Of these, 2617 (56.1%) tested SARS-CoV-2 positive and contributed data to this interim budesonide primary analysis; 751 budesonide, 1028 usual care and 643 to other interventions. Time to first self-reported recovery was shorter in the budesonide group compared to usual care (hazard ratio 1.208 [95% BCI 1.076 - 1.356], probability of superiority 0.999, estimated benefit [95% BCI] of 3.011 [1.134 - 5.41] days). Among those in the interim budesonide primary analysis who had the opportunity to contribute data for 28 days follow up, there were 59/692 (8.5%) COVID-19 related hospitalizations/deaths in the budesonide group vs 100/968 (10.3%) in the usual care group (estimated percentage benefit, 2.1% [95% BCI -0.7% - 4.8%], probability of superiority 0.928). CONCLUSIONS In this updated interim analysis, inhaled budesonide reduced time to recovery by a median of 3 days in people with COVID-19 with risk factors for adverse outcomes. Once 28 day follow up is complete for all participants randomized to budesonide, final analyses of time to recovery and hospitalization/death will be published. (Funded by the National Institute of Health Research/ United Kingdom Research Innovation [MC_PC_19079]; PRINCIPLE ISRCTN number, ISRCTN86534580.)

Does MRI add value in general practice for patients with traumatic knee complaints? A 1-year randomised controlled trial

2018 ◽  
Vol 53 (20) ◽  
pp. 1285-1292 ◽  
Author(s):  
Nynke M Swart ◽  
Kim van Oudenaarde ◽  
Sita MA Bierma-Zeinstra ◽  
Hans JL Bloem ◽  
Wilbert B van den Hout ◽  
...  
Keyword(s):  
General Practice ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Primary Outcome Measure ◽  
Care Group ◽  
Randomised Controlled ◽  
Daily Function

ObjectiveTo determine whether referral to MRI by the general practitioner (GP) is non-inferior to usual care (no access to MRI by GPs) in patients with traumatic knee complaints regarding knee-related daily function.MethodsThis was a multicentre, non-inferiority randomised controlled trial with 1-year follow-up. GPs invited eligible patients during or after their consultation. Eligible patients (18–45 years) consulted a GP with knee complaints due to a trauma during the previous 6 months. Patients allocated to the MRI group received an MRI at (median) 7 (IQR 1–33) days after the baseline questionnaire. Patients in the usual care group received information on the course of knee complaints, and a referral to a physiotherapist or orthopaedic surgeon when indicated. The primary outcome measure was knee-related daily function measured with the Lysholm scale (0 to 100; 100=excellent function) over 1 year, with a non-inferiority margin of 6 points.ResultsA total of 356 patients were included and randomised to MRI (n=179) or usual care (n=177) from November 2012 to December 2015. MRI was non-inferior to usual care concerning knee-related daily function during 1-year follow-up, for the intention-to-treat (overall adjusted estimate: 0.33; 95% CI −1.73 to 2.39) and per-protocol (overall adjusted estimate: 0.06; 95% CI −2.08 to 2.19) analysis. There were no differences between both groups in the amount of patients visiting other healthcare providers.ConclusionMRI in general practice in patients with traumatic knee complaints was non-inferior to usual care regarding knee-related daily function during 1-year follow-up.Trial registration numberNTR3689.

Abstract P191: Telephone-based Mindfulness Training In Diverse Prehypertensive Women: Results Of A Pilot Randomized Controlled Trial

Circulation ◽  
2021 ◽  
Vol 143 (Suppl_1) ◽  
Author(s):  
Jolaade Kalinowski ◽  
Sheila F Castaneda ◽  
Matthew A Allison ◽  
Zoe T Duberstein ◽  
Kiranjot Kaur ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Usual Care ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Random Effect ◽  
Median Number ◽  
Mindfulness Training ◽  
Group Differences ◽  
Foreign Born

Introduction: Chronic stress is associated with incident hypertension and is a promising intervention target for lowering blood pressure (BP), particularly in women. Growing evidence suggests that mindfulness-based interventions can reduce BP and improve psychological outcomes but the in-person format of traditional programs limits access. The goal of this study was to evaluate the feasibility, acceptability and effects of telephone-delivered mindfulness-based cognitive therapy (MBCT-T) in women with prehypertension. Methods: We conducted a pilot RCT in which 37 women meeting JNC 7 criteria for prehypertension (SBP 120-139 mmHg or DBP 80-89 mmHg) and not taking antihypertensive medication were recruited from outpatient clinics or via the EHR. Eligible participants were randomized to usual care or MBCT-T, which involved 8 weekly 1-hour phone sessions delivered to small groups by a trained instructor. Outcomes included feasibility (session completion), acceptability (Client Satisfaction Questionnaire [CSQ]), SBP (mean of 3 clinic BP measurements), perceived stress (PSS-10) and depressive symptoms (PHQ-8). Linear mixed models with a random effect of intervention cohort were performed to compare 3-month changes in outcomes between study arms, adjusting for age and ethnicity. Results: The mean age was 50.7±17.7, 68% of participants were racial/ethnic minorities, and baseline SBP/DBP was 127.8±6.2/77.5±7.2 mmHg. There were no significant differences between study arms in demographics or baseline characteristics. The median number of sessions completed was 6 of 8. Fewer sessions were completed by employed vs. unemployed women (4.5 vs. 7.8, t=3.55, p=.003) and by foreign-born vs. U.S.-born women (2.8 vs. 5.9, t=1.87, p=.08). Overall 3-month retention was 89% but follow-up BP was missing in ~50% of participants due to COVID-19 research restrictions. Three-quarters of MBCT-T participants reported high satisfaction with the intervention (CSQ24). In the subgroup with complete follow-up data, SBP declined in both study arms but there was no significant between-group difference (p=0.51). Conversely, greater reductions in perceived stress and depressive symptoms were observed in the MBCT-T arm vs. usual care (between-group differences of 3.63 [PSS-10; p=.163] and 2.90 [PHQ-8; p=.008]). In per-protocol analyses limited to MBCT-T participants who completed ≥4 sessions, effects were larger for perceived stress and similar for depressive symptoms (between-group differences of 6.17 [PSS-10; p=.012] and 2.77 [PHQ-8; p=.025]). Conclusions: Results support the feasibility and acceptability of telephone-based mindfulness training in diverse women with prehypertension. Promising findings for stress and depressive symptoms suggest further studies are warranted. Strategies to address barriers to participation, particularly among working women and minorities, are needed.

scholarly journals Clinical Outcomes of Telemonitoring for Patients on Warfarin after Discharge from Hospital

2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Natthaporn Sudas Na Ayutthaya ◽  
Itsarawan Sakunrak ◽  
Teerapon Dhippayom
Keyword(s):  
Usual Care ◽  
Clinical Outcomes ◽  
Usual Care Group ◽  
Controlled Trial ◽  
Intervention Group ◽  
International Normalized Ratio ◽  
Target Range ◽  
Care Group ◽  
The Impact

Objective. To evaluate the impact of telephone follow-up service on clinical outcomes in patients on warfarin when discharged from hospital. Methods. This randomized controlled trial was conducted at a general hospital in Thailand. Patients aged ≥20 years who were prescribed warfarin when discharged were eligible to participate in this study. They were randomly allocated, using a computer generated random number, to receive either telephone follow-up intervention or usual care. Participants in the intervention group received telephone follow-up by hospital pharmacists for three months. During each telephone call, pharmacists performed medicine use reviews and addressed any problems identified. Key Findings. A total of 50 patients participated in this study. The proportion of international normalized ratio (INR) values in the target range for the telephone follow-up group (36/79, 45.6%) was higher than that in the usual care group (19/79, 24.1%), p=0.005. The mean time in the therapeutic range (TTR) in the telephone follow-up group was also higher than that in the usual care group (49.8±34.3 versus 28.0±27.5, p=0.017). All patients in the usual care group experienced one or more out-of-range INR values (25/25, 100%) compared to 21 out of 25 (84%) in the telephone follow-up group, p=0.037. There was no difference between the two groups in the incidence of complications or adverse events associated with warfarin. Conclusions. The telephone follow-up service in recently discharged patients helps them achieve and maintain their INR target. This anticoagulant supportive service should be promoted to patients receiving warfarin therapy after discharge. This trial is registered with TCTR20180614006 (Thai Clinical Trials Registry).

scholarly journals Long-term outcome of two forms of randomised benzodiazepine discontinuation

2006 ◽  
Vol 188 (2) ◽  
pp. 188-189 ◽  
Author(s):  
R. C. Oude Voshaar ◽  
W. J. M. J. Gorgels ◽  
A. J. J. Mol ◽  
A. J. L. M. Van Balkom ◽  
J. Mulder ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Term Outcome ◽  
Long Term Outcome ◽  
Randomised Controlled

SummaryAbouttwo-thirds of long-term users of benzodiazepines in the population are able to discontinue this drug with the aid of supervised programmes for tapering off. Little is known about the long-term outcome of such programmes, and they have never been compared with usual care. After a 15-month follow-up of a randomised controlled trial comparing such a programme with and without psychotherapy with usual care, we found significantly higher longitudinal abstinence rates in long-term benzodiazepine users who received a benzodiazepine tapering-off programme without psychotherapy (25 out of 69, 36%) compared with those who received usual care (5 out of 33, 15%; P=0.03).

scholarly journals Randomised controlled study of two counselling models at the Swedish alcohol helpline: Effectiveness and sustainability outcomes at 12-month follow-up

2021 ◽  
pp. 145507252110078
Author(s):  
Thi-Thuy-Dung Nguyen ◽  
Eleonor Säfsten ◽  
Filip Andersson ◽  
Maria Rosaria Galanti
Keyword(s):  
Alcohol Use ◽  
Usual Care ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Risk Level ◽  
Care Group ◽  
Structured Intervention ◽  
Randomised Controlled ◽  
Level Reduction

Aim: This two-arm parallel randomised controlled trial explored the effectiveness of a brief counselling model compared with the usual multi-session counselling at an alcohol telephone helpline. Methods: A total of 320 callers who contacted the Swedish Alcohol Helpline (SAH) because of hazardous or harmful alcohol use were randomised to either brief structured intervention (self-help booklet plus one proactive call) or usual care (multi-session telephone counselling). The primary outcome was a downward shift in risk level at 12-month follow-up compared with baseline, based on self-reports. Sustained risk level reduction throughout the whole follow-up was also assessed as secondary outcome. Results: Both interventions were significantly associated with a shift to a lower level of risky alcohol use (75% among participants in the brief structured intervention, and 70% in the usual care group) after 12 months. There was no difference between the two interventions in the proportions changing alcohol use or sustaining risk level reduction. Conclusion: In the context of telephone helplines, minimal and extended interventions appear to be equally effective in promoting long-term change in alcohol use.

Effect of Artificial Intelligence on Nutritional Status of children post cardiac surgery; A Randomized Controlled Trial (Preprint)

2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra
Keyword(s):  
Nutritional Status ◽  
Usual Care ◽  
Usual Care Group ◽  
Mobile Application ◽  
Controlled Trial ◽  
Intervention Group ◽  
Care Group ◽  
Randomized Controlled ◽  
Nutritional Status Of Children ◽  
Post Cardiac Surgery

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.

The Natural History of Back Pain after a Randomised Controlled Trial of Acupuncture Vs Usual Care – Long Term Outcomes

2007 ◽  
Vol 25 (4) ◽  
pp. 121-129 ◽  
Author(s):  
Stephanie L Prady ◽  
Kate Thomas ◽  
Lisa Esmonde ◽  
Simon Crouch ◽  
Hugh MacPherson
Keyword(s):  
Back Pain ◽  
Randomised Controlled Trial ◽  
Usual Care ◽  
Controlled Trial ◽  
Bodily Pain ◽  
Care Group ◽  
Long Term Outcomes ◽  
Short Term Treatment ◽  
Randomised Controlled

Introduction There is growing evidence about the effectiveness of acupuncture in the short term treatment of chronic low back pain but little is known about long term outcomes. To address this question we followed up participants of a past randomised controlled trial of acupuncture to assess outcomes after 5.5 to 7 years. Methods A postal questionnaire assessing pain, quality of life, disability, experience with back pain and healthcare resource use was sent to all 239 participants of the York Acupuncture for Back Pain trial. Results Response to the survey was low at 43.9%. Pain measured by the SF-36 Bodily Pain dimension was maintained in the acupuncture group since the last follow up 3.5 to 5 years previously. The usual care group had improved over the intervening years and there was now no evidence of a difference between the groups (difference −0.4 points, 95% confidence interval −10.1 to 9.7). The results were unchanged on sensitivity analysis using multiple imputation. In both groups back pain had not completely resolved and worry about back health was moderate. Physiotherapy and acupuncture were used at similar rates for continuing treatment. Discussion We theorise that exposure to a short course of acupuncture speeds natural recovery from a back pain episode, but improvements plateau after two years. Acupuncture is often accessed privately for long term management of back pain but is rarely available within the health service. While our study methods were robust, the low response rate means that our findings should be interpreted with caution.

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